이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

Efficacy and Safety of GLPG0634 in Subjects With Active Crohn's Disease

2016년 2월 21일 업데이트: Galapagos NV

Double-Blind, Randomized, Placebo-Controlled, Multi-Centre Study to Investigate the Efficacy and Safety of GLPG0634 in Subjects With Active Crohn's Disease With Evidence of Mucosal Ulceration

  • 180 patients suffering from active Crohn's disease with evidence of mucosal ulceration will be evaluated for improvement of disease activity (efficacy) when taking GLPG0634 or matching placebo once daily for 20 weeks in addition to their stable background treatment.
  • During the course of the study, patients will also be examined for any side effects that may occur (safety and tolerability), and the amount of GLPG0634 present in the blood (Pharmacokinetics) as well as the effects of GLPG0634 on disease- and mechanism of action-related parameters in the blood and stool (Pharmacodynamics) will be determined. Also, the effects GLPG0634 administration on subjects' quality of life will be evaluated.

연구 개요

상태

완전한

정황

개입 / 치료

상세 설명

  • 180 patients suffering from active Crohn's disease with evidence of mucosal ulceration will be evaluated when taking GLPG0634 or matching placebo once daily in addition to their stable background treatment. The population will include 50% anti-TNF naïve patients and 50% of subjects previously exposed to anti-TNF.
  • The study will consist of 2 parts, with total treatment duration of 20 weeks. Randomisation in Part 1 will be stratified according to subject's previous anti-TNF exposure, C-reactive protein (CRP) level at Screening and oral corticosteroid use at Day -1. However, at Week 10, subjects will be re-randomized automatically and stratified according to the subject's clinical response (reduction of Crohn's Disease Activity Index (CDAI) of 100 points), previous anti-TNF exposure and corticosteroid use at Day -1 to receive GLPG0634 200 mg q.d., 100 mg q.d. doses, or matching placebo q.d. in a blinded fashion. In Part 2, all will continue the study until Week 20.
  • As efficacy parameters, the ability to achieve clinical response or remission, endoscopic response & remission as well as mucosal healing with GLPG0634 given once daily compared to placebo will be evaluated after 10 weeks of treatment. In subjects who achieved clinical remission at Week 10, maintenance of the remission will be assessed during Part 2 of the study.
  • During the course of the study, patients will also be examined for any side effects that may occur (safety and tolerability), and the amount of GLPG0634 present in the blood (Pharmacokinetics) as well as the effects of GLPG0634 on disease- and mechanism of action-related parameters in the blood and stool (Pharmacodynamics) will be determined. Also, the effects of different doses and dose regimens of GLPG0634 administration on subjects' quality of life will be evaluated.

연구 유형

중재적

등록 (실제)

175

단계

  • 2 단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

  • 독일
      • Berlin, 독일
        • DRK Clinics Berlin Westend
      • Frankfurt-am-Main, 독일
        • Interdisciplinary Crohn Colitis Center Rhein Main
      • Hamburg, 독일
        • Asklepios West Hospital Hamburg
      • Jena, 독일
        • University Hospital Jena
      • Kiel, 독일
        • University Hospital Schleswig-Holstein
      • Magdeburg, 독일
        • University Hospital Magdeburg
      • Minden, 독일
        • Gastroenterology Group Practice Minden
      • Oldenburg, 독일
        • Internal Medicine Group Practice Oldenburg
  • 러시아 연방
      • Barnaul, 러시아 연방
        • Territorial Clinical Hospital
      • Kazan, 러시아 연방
        • State Medical University
      • Krasnoyarsk, 러시아 연방
        • Territorial Clinical Hospital
      • Moscow, 러시아 연방
        • City Clinical Hospital #24
      • Moscow, 러시아 연방
        • A.N. Ryzhikh State Research Center for Coloproctology
      • Moscow, 러시아 연방
        • Moscow Clinical Research Center
      • Moscow, 러시아 연방
        • Vladimirsky Regional Clinical Research Institute
      • Nizhny Novgorod, 러시아 연방
        • Semashko Nizhny Novgorod Regional Clinical Hospital
      • Novosibirsk, 러시아 연방
        • City Clinical Hospital #12
      • Saint Petersburg, 러시아 연방
        • City Clinical Hospital #31
      • Saint Petersburg, 러시아 연방
        • First Pavlov State Medical University
      • Saint Petersburg, 러시아 연방
        • Mechnikov North-Western State Medical University
      • Saint Petersburg, 러시아 연방
        • St. Elizabeth City Hospital
  • 루마니아
      • Bucharest, 루마니아
        • Colentina Clinical Hospital
      • Bucharest, 루마니아
        • Fundeni Clinical Institute
      • Cluj-Napoca, 루마니아
        • Medical Center for Gastroenterology
      • Timisoara, 루마니아
        • Center for Gastroenterology, Ltd
  • 벨기에
      • Brussels, 벨기에
        • St. Pierre University Hospital Center
      • Brussels, 벨기에
        • University Hospital Saint Luc
      • Ghent, 벨기에
        • University Hospital Ghent
      • Leuven, 벨기에
        • University Hospitals Leuven
      • Liege, 벨기에
        • CHR de la Citadelle
      • Liege, 벨기에
        • Clinic Saint Joseph
  • 영국
      • Birmingham, 영국
        • Queen Elizabeth Hospital
      • Bournemouth, 영국
        • Royal Bournemouth Hospital
      • Harrow, 영국
        • St Mark's Hospital
      • Manchester, 영국
        • Manchester Royal Infirmary
  • 체코 공화국
      • Hradec Kralove, 체코 공화국
        • Hepato-Gastroenterology HK Ltd.
      • Olomouc, 체코 공화국
        • University Hospital Olomouc
      • Pilsen, 체코 공화국
        • Outpatient Clinic of Internal Medicine and Gastroenterology
      • Prague, 체코 공화국
        • Institute of clinical and experimental medicine
      • Usti nad Labem, 체코 공화국
        • Masaryk's Hospital Usti Nad Labem
      • Znojmo, 체코 공화국
        • Hospital Znojmo
  • 폴란드
      • Bydgoszcz, 폴란드
        • Jan Biziel University Hospital #2
      • Lodz, 폴란드
        • Saint Family Hospital Medical Center
      • Tychy, 폴란드
        • H-T. Medical Center
      • Warsaw, 폴란드
        • Maternal, Pediatric and Adolescent Healtcare Centre, Gastroenterology Diagnostic Facility for Adults
      • Warsaw, 폴란드
        • Vivamed
      • Warsaw, 폴란드
        • Clinical Hospital of Ministry of Internal Affairs and Administration
      • Wroclaw, 폴란드
        • Active Health Center
  • 프랑스
      • Clermont-Ferrand, 프랑스
        • Hospital Gabriel Montpied
      • Clichy, 프랑스
        • Beaujon Hospital
      • Dijon, 프랑스
        • Dijon University Hospital Center
      • Grenoble, 프랑스
        • Hospital Michallon
      • Lille, 프랑스
        • Lille Regional University Hospital Center
      • Marseille, 프랑스
        • North Hospital
      • Nice, 프랑스
        • Archet Hospital
      • Saint Etienne, 프랑스
        • Saint Etienne University Hospital Center
  • 헝가리
      • Balatonfured, 헝가리
        • Drug Research Center Ltd.
      • Budapest, 헝가리
        • Semmelweis University
      • Budapest, 헝가리
        • ClinExpert Medical Center
      • Budapest, 헝가리
        • Szent Margit Hospital
      • Debrecen, 헝가리
        • University of Debrecen, Medical and Health Science Center
      • Gyula, 헝가리
        • Bekes County Pandy Kalman Hospital
      • Szekszard, 헝가리
        • Tolna County Balassa Janos Hospital

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Inclusion Criteria:

  • Male or female subjects between 18 and 75 years
  • Documented history of ileal, colonic, or ileocolonic CD
  • CDAI score ≥ 220 to ≤ 450
  • Evidence of active inflammation as demonstrated by endoscopic confirmation of active disease
  • Subjects previously not exposed to anti-TNF treatment (TNF-naïve) or subjects previously exposed to anti-TNF therapy at a registered dose, that has been discontinued at least 8 weeks prior to Screening and deemed by the treating physician as a primary or secondary non-responder or intolerant (TNF-experienced)
  • Continuation of concurrent treatment with oral steroids (≤30 mg prednisolone eq/day), mesalazine, olsalazine, CD-related antibiotics and probiotics at stable dose is allowed
  • Previous exposure to immunomodulators is permitted, but must be discontinued
  • Haematology and biochemistry lab parameters within predefined ranges as stated in the protocol

Exclusion Criteria:

  • Diagnosis of indeterminate colitis, ulcerative colitis (UC), or clinical findings suggestive of UC
  • Stoma, gastric or ileoanal pouch, procto- or total colectomy, symptomatic stenosis or obstructive strictures, history of bowel perforation, (suspected) abscess; actively draining fistulae
  • Subject who has had surgical bowel resections within the past 6 months, short bowel syndrome or is receiving tube feeding, defined formula diets, or parenteral alimentation
  • Subject with positive Clostridium difficile toxin stool assay or evidence of any other gastrointestinal infection
  • Subject who has received non-permitted IBD therapies within specified timeframes, depending on the medication, as stated in the protocol
  • Subject with a (previous history of) dysplasia of the gastrointestinal tract
  • Concurrent gastro-intestinal malignancy or a history of cancer elsewhere
  • History of lymphoproliferative disease
  • Known active infection of any kind, current therapy for chronic infection or history of specific infections as stated in the protocol
  • Subject who is pregnant, lactating or not willing to maintain highly effective birth control methods during the course of the study and 12 weeks thereafter

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 네 배로

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: GLPG0634 200 mg QD
2 tablets of 100 mg GLPG0634 in the morning
의약품: GLPG0634
100 mg oral tablet, intake once daily for 20 weeks
다른 이름들:
  • GLPG0634 태블릿
실험적: GLPG0634 100 mg QD
1 tablet of 100 mg GLPG0634 and 1 placebo tablet in the morning
의약품: GLPG0634
100 mg oral tablet, intake once daily for 20 weeks
다른 이름들:
  • GLPG0634 태블릿
의약품: Placebo
placebo oral tablets, intake once daily for 20 weeks
다른 이름들:
  • 위약 정제
위약 비교기: Placebo QD
2 placebo tablets in the morning
의약품: Placebo
placebo oral tablets, intake once daily for 20 weeks
다른 이름들:
  • 위약 정제

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Percentage of subjects achieving clinical remission at Week 10
기간: Week 10
Percentage of subjects achieving clinical remission as defined by a Crohn's Disease Activity Index score < 150 points
Week 10

2차 결과 측정

결과 측정
측정값 설명
기간
Percentage of subjects achieving clinical remission
기간: Up to Week 20
Percentage of subjects achieving clinical remission as defined by a Crohn's Disease Activity Index score < 150 points, assessed at every visit
Up to Week 20
Percentage of subjects achieving clinical response
기간: Up to Week 20
Percentage of subjects achieving clinical response as defined by a decrease in Crohn's Disease Activity Index score of at least 100 points, assessed at every visit
Up to Week 20
Percentage of subjects achieving endoscopic remission at Week 10
기간: Week 10
Percentage of subjects achieving endoscopic remission as defined by a reduction of Simplified Endoscopy Score for Crohn's Disease (SES-CD) score ≤ 4, with ulcerated surface subscore no greater than 1 in any segment at Week 10
Week 10
Percentage of subjects achieving endoscopic response at Week 10
기간: Week 10
Percentage of subjects achieving endoscopic response as defined by a reduction of Simplified Endoscopy Score for Crohn's Disease (SES-CD) score by at least 50% from Screening at Week 10
Week 10
Percentage of subjects achieving mucosal healing at Week 10
기간: Week 10
Percentage of subjects achieving mucosal healing as defined by a Simplified Endoscopy Score for Crohn's Disease (SES-CD) score equal to 0 at Week 10
Week 10
Change from Baseline in Crohn's Disease Activity Index score
기간: Up to Week 20
Change from Baseline in Crohn's Disease Activity Index score, assessed at every visit
Up to Week 20
Change from Screening in endoscopic score
기간: Week 10
Change from Screening in endoscopic Simplified Endoscopy Score for Crohn's Disease (SES-CD) score at Week 10
Week 10
Change from Screening in histopathology biopsy score
기간: Week 10
Change from Screening in histopathology biopsy score at Week 10
Week 10
Change from Baseline in Subjects' Quality of Life (based on the Inflammatory Bowel Disease Questionnaire (IBDQ) questionnaire score)
기간: Up to Week 20
Change from Baseline in Subjects' Quality of Life based on the IBDQ questionnaire score at Week 10 and Week 20
Up to Week 20
The number of subjects with adverse events
기간: From screening up to 2 weeks after last dose
To evaluate the safety and tolerability of GLPG0634 in comparison with placebo in terms of adverse events (AEs)
From screening up to 2 weeks after last dose
The number of subjects with abnormal lab tests
기간: From screening up to 2 weeks after last dose
To evaluate the safety and tolerability of GLPG0634 in comparison with placebo in terms laboratory test abnormalities
From screening up to 2 weeks after last dose
The number of subjects with abnormal vital signs
기간: From screening up to 2 weeks after last dose
To evaluate the safety and tolerability of GLPG0634 in comparison with placebo in terms of abnormalities in vital signs
From screening up to 2 weeks after last dose
The number of subjects with abnormal ECG
기간: From screening up to 2 weeks after last dose
To evaluate the safety and tolerability of GLPG0634 in comparison with placebo in terms of abnormalities in electrocardiogram (ECG)
From screening up to 2 weeks after last dose
The plasma levels of GLPG0634 and its metabolite
기간: Up to Week 20
To characterize the pharmacokinetics (PK) of GLPG0634 and its metabolite by measuring the amount in plasma from Week 2 up to Week 20 at every visit
Up to Week 20
The change versus Baseline in levels of immune- and inflammation-related parameters in whole blood and serum
기간: Up to Week 20
To characterize the pharmacodynamics (PD) of GLPG0634 and its metabolite by measuring the levels of immune- and inflammation-related parameters in whole blood and serum
Up to Week 20
The change versus Baseline in levels of faecal calprotectin
기간: Up to Week 20
To characterize the pharmacodynamics (PD) of GLPG0634 and its metabolite by measuring the levels of faecal calprotectin
Up to Week 20
The change versus Baseline in microbial communities in stool samples
기간: Up to Week 10
To characterize the effects of GLPG0634 and its metabolite on the microbial communities by measuring the levels of predominant microbiota in stool samples
Up to Week 10

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Galapagos NV

수사관

  • 연구 책임자: Pille Harrison, MD, Galapagos NV

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작

2014년 2월 1일

기본 완료 (실제)

2015년 11월 1일

연구 완료 (실제)

2016년 2월 1일

연구 등록 날짜

최초 제출

2014년 1월 27일

QC 기준을 충족하는 최초 제출

2014년 1월 27일

처음 게시됨 (추정)

2014년 1월 29일

연구 기록 업데이트

마지막 업데이트 게시됨 (추정)

2016년 2월 23일

QC 기준을 충족하는 마지막 업데이트 제출

2016년 2월 21일

마지막으로 확인됨

2016년 2월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • GLPG0634-CL-211
  • 2013-002857-32 (EudraCT 번호)

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

크론병에 대한 임상 시험

GLPG0634에 대한 임상 시험

유사한 임상시험 검색

스폰서 및 공동 작업자

건강 상태

약물 개입

CROs by country

CROs in Montenegro

정황

희귀 질병

약물 개입

식이 보충제

스폰서 / 협력자

위치

구독하다